A Study of LY3556050 in Adult Participants With Diabetic Peripheral Neuropathic Pain

Phase 2

Completed

• Conditions: Diabetic Peripheral Neuropathy
• Interventions: Drug: LY3556050; Drug: Placebo

• Registration Number: NCT06074562
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The main purpose of this study is to determine the safety and efficacy of LY3556050 versus placebo in participants with diabetic peripheral neuropathic pain (DPNP). The study will lasts approximately 24 weeks, across 3 study periods.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-03
• Study First Submitted QC: 2023-10-03
• Study Start: 2023-10-05
• Study First Posted: 2023-10-10
• Primary Completion: 2025-06-11
• Study Completion: 2025-06-11
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-02
• Last Update Posted: 2025-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 405

Inclusion Criteria

• Have a history and current diagnosis of Type 1 Diabetes (T1D) or Type 2 Diabetes (T2D) diagnosed for at least 6 months prior to screening.

• Have a stable glycemic control on stable diabetes treatment regimen for at least 90 days prior to day 1 with a hemoglobin A1c (HbA1c) ≤10 for T1D and HbA1c ≤11 for participants with T2D at time of screening.

• Have a history of daily peripheral neuropathic pain for at least 12 weeks based on participant report or medical history.

• Have a visual analog scale (VAS) pain value ≥40 and <95 during screening.

• Have presence of diabetic peripheral neuropathy of symmetrical nature and in lower extremities for ≥6 months and diagnosed by a score of Part B ≥3 on Michigan Neuropathy Screening Instrument

• Are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain-relieving therapies (for example, physical therapy) and will not start any new nonpharmacologic pain-relieving therapies during study participation.

• Are willing to discontinue all medications taken for chronic pain conditions, except allowed concomitant pain medication permitted per protocol, for the duration of the study

  • Have a body mass index ≤45 kilogram/square meter (kg/m²) (inclusive).
  • Are men, or women able to abide by reproductive and contraceptive requirements.

Exclusion Criteria

• History of other potentially causative and/or confounding sources of pain that may impair self-assessment of pain due to DPNP.
• Have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest (for example, ablation techniques.
• Have had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision.
• Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide.
• Have in the judgement of the investigator, an acute, serious, or unstable medical condition or a history or presence of any other medical illness that would preclude study participation.
• Have a positive HIV test result at screening.
• Have a surgery planned during the study for any reason.
• Have a substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3556050 Dose 1	LY3556050	Participants will receive LY3556050 orally.
LY3556050 Dose 2	LY3556050	Participants will receive LY3556050 orally.
Placebo	Placebo	Participants will receive placebo orally.
LY3556050 Dose 3	LY3556050	Participants will receive LY3556050 orally.

Primary Outcome Measures

Name	Time	Method
Mean Change from Baseline for Average Pain Intensity Numeric Rating Scale (API-NRS)	Baseline, Week 12

Secondary Outcome Measures

Name	Time	Method
Mean Change from Baseline for Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form (SF)8a	Baseline, Week 12
Mean Change from Baseline for PROMIS Sleep Disturbance (SD)8b	Baseline, Week 12
Mean Change from Baseline for Patient's Global Impression of Illness (PGI) Severity as Measured by PGI-Severity	Baseline, Week 12
Mean Change from Baseline for Patient's Global Impression of Illness Status as Measured by PGI-Status	Baseline, Week 12
Mean Change from Baseline for Patient's Global Impression of Change as Measured by PGI-Change	Baseline, Week 12
Mean Change from Baseline for Neuropathy Total Symptom Score-6 (NTSS-6)	Baseline, Week 12
Summary of Frequency, Timing and Amount of Rescue Medication Used During the Treatment Period	Baseline to Week 12
Mean Change from Baseline for Worst Pain Intensity Numeric Rating Scale (WPI-NRS)	Baseline, Week 12
Mean Change from Baseline for Pain Interference with Sleep	Baseline, Week 12
Mean Change from Baseline for PROMIS Physical Functioning Short Form (SF)10a	Baseline, Week 12
Pharmacokinetics (PK): Plasma Concentration of LY3556050	Baseline to Week 12

Trial Locations

Locations (68)

The Institute for Liver Health II dba Arizona Clinical Trials - Mesa; 🇺🇸 Chandler, Arizona, United States

Headlands Research - Scottsdale; 🇺🇸 Scottsdale, Arizona, United States

Orange Grove Family Practice; 🇺🇸 Tucson, Arizona, United States

Preferred Research Partners; 🇺🇸 Little Rock, Arkansas, United States

Hope Clinical Research, Inc.; 🇺🇸 Canoga Park, California, United States

Valley Clinical Trials, Inc.; 🇺🇸 Northridge, California, United States

Northern California Research - Sacramento; 🇺🇸 Sacramento, California, United States

CMR of Greater New Haven, LLC; 🇺🇸 Hamden, Connecticut, United States

Suncoast Research Group; 🇺🇸 Miami, Florida, United States

New Horizon Research Center; 🇺🇸 Miami, Florida, United States

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